The heater-cooler devices, used during open heart surgery to regulate temperature, never come into contact with patients. However, the machines are at risk of accumulating biofilm, which contains harmful bacteria that can be transmitted to patients through the air during surgery. Between Penn State Hershey Medical Center and WellSpan York Hospital, at least six deaths have been linked to the devices. In addition to finding the manufacturer-issued device-cleaning protocol to be ineffective, the FDA’s investigation revealed the devices were misbranded and the company was operating without an approved application for pre-market approval.
“Given the serious nature of the violations … the FDA is taking steps to refuse entry of these devices in the U.S., known as ‘detention without physical examination,’ until these violations are corrected,” the letter reads.
The FDA has demanded LivaNova to provide a written response detailing its plans to correct the numerous violations cited in the warning letter.
More articles on infection control:
Lung transplant patient sues UPMC Presbyterian over fungal infection
WellSpan York notifies 1,300 patients of possible bacterial exposure after 4 die from infection
CMS launches 3-year pilot project to improve infection control assessment for hospitals
